Fisher Wallace Laboratories, Inc., headquartered in

New York City New York, often called New York City (NYC), is the most populous city in the United States, located at the southern tip of New York State on one of the world's largest natural harbors. The city comprises five boroughs, each coextensive w ...

, markets the Fisher Wallace Stimulator, a

cranial electrotherapy stimulation Cranial electrotherapy stimulation (CES) is a form of neurostimulation that delivers a small, pulsed, alternating current via electrodes on the head. CES is used with the intention of treating a variety of conditions such as anxiety, clinical depr ...

(CES) device. The company was founded in 2007 by entrepreneur Charles Avery Fisher, son of electronics pioneer

Avery Fisher Avery Robert Fisher (March 4, 1906 – February 26, 1994) was an amateur violinist, a pioneer in the field of high fidelity sound reproduction, founder of the Philharmonic Radio Company and Fisher Electronics, and a philanthropist who donated mi ...

, and Martin Wallace.Melinda Beck for the ''Wall Street Journal''. Jan. 11, 201
"Using Electricity, Magnets for Mental Illness"
/ref> The company acquired its lead product from Saul and Bernard Liss in 2006.

Jessa Gamble Jessa Gamble (born April 25, 1979), née Sinclair, is a Canadian and English author and co-owner of the science blog The Last Word on Nothing. Her book, ''The Siesta and the Midnight Sun: How Our Bodies Experience Time'' (Penguin Group), document ...

New technologies are emerging that could radically reduce our need to sleep – if we can bear to use them
''Aeon Magazine'' ''Inc.'' magazine rated the company as being #983 (in 2014) and #1447 (in 2015) in its "Inc. 5000" listing. (In archive link, click on list that leads to #1447.) The Lisses had already obtained 510K marketing clearance from the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

to treat anxiety, depression, and insomnia when Fisher-Wallace acquired it. Subsection: "Contemporary Devices and Clinical Applications". Fisher-Wallace renamed the device as the FW-100 Cranial Stimulator Device, and it was approved for marketing by

Health Canada Health Canada (HC; )Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary units, department of the Gove ...

in 2014 under Licence No. 92984; in 2015

received a complaint about Fisher Wallace's marketing on its website and sent an enforcement letter concerning the false marketing, which the company corrected. A 2014 Cochrane review found insufficient evidence to determine whether CES devices with alternating current are safe and effective for treating depression. Fisher-Wallace is a late entry to the CES field; such devices have been marketed since the 1940s, especially in Russia. It has heavily marketed its device via YouTube and other media with pitches that, according to Jessa Gamble writing in ''

Aeon The word aeon , also spelled eon (in American and Australian English), originally meant "life", "vital force" or "being", "generation" or "a period of time", though it tended to be translated as "age" in the sense of "ages", "forever", "timele ...

'', have "all the trappings of a late-night infomercial". Fisher was credited by ''Neurotech Reports'' editor and publisher James Cavuoto with playing a leading role in the FDA's 2014 withdrawal of its earlier proposal to require companies marketing CES devices to conduct new clinical trials to prove the safety and efficacy of the devices and to submit

Premarket Approval The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of ...

applications in order to continue marketing the devices; the company had alleged that the FDA improperly barred an expert in the field from attending a 2014 advisory meeting to discuss the proposed regulation. In 2016, in response to the FDA's next effort to regulate the device class, the company alleged that there was "evidence of regulatory misconduct" and called for an investigation.Marie Thibault for MDDI. April 20, 201
Patients, Clinicians Advocate for Cranial Electrotherapy Stimulators
/ref>

References

{{Reflist

External links

Fisher Wallace Laboratories website

"Electroceutical" Ads Are Here. What Will Regulators Say?
Roland Nadler for the Stanford Law and Biosciences Blog. October 24, 2013 Electronics companies established in 2007 Manufacturing companies based in New York City Medical technology companies of the United States 2007 establishments in New York City